FDA.reportPublic FDA data

NDC 51672-4060-01 - Amcinonide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-4060
Requested NDC
51672-4060-01
Package NDCs from labels
51672-4060-1, 51672-4060-2, 51672-4060-3, 51672-4060-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2025-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amcinonide Cream USP, 0.1% Amcinonide Ointment USP, 0.1%Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2025-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4060-1Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-1Amcinonide15 g in 1 TUBEOINTMENT155
51672-4060-2Amcinonide30 g in 1 TUBEOINTMENT305
51672-4060-2Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-3Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-3Amcinonide60 g in 1 TUBEOINTMENT605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4060AMCINONIDE CREAM AMCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 6 package rows20250406_ac5c3e79-52f7-434e-92ae-24bd32b45edc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmcinonideACTIVE INGREDIENT423W026MA9AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
AmcinonideACTIVE MOIETY423W026MA9AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
lactic acidINACTIVE INGREDIENT33X04XA5ATAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitolINACTIVE INGREDIENT506T60A25RAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 58 · 1,141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Vanilla Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack71bb5177-20af-4aee-ab02-6687c51fe0a12026-03-14WarningsExact identifier
unii: 4T6H12BN9U
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Panama Jack SPF 45 Mango Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jackbd0f6577-9638-4319-b759-348f357ce3972026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Dreamsicle Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack34e89add-ca63-4b66-bdf5-d47403c917702026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Tropical Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jacka271ec3c-e0ea-4100-9a56-b127bbfef3472026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
unii: 4T6H12BN9U
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.